With Nipent
With IFN
N=180
N=176
Upper Respiratory Infection
13
8
Rhinitis
11
15
Herpes Zoster
8
1
Pharyngitis
8
11
Viral Infection
8
17
Infection (Unspecified)
7
2
Sinusitis
6
4
Cellulitis
6
3
Bacterial Infection
5
4
Pneumonia
5
7
Conjunctivitis
4
2
Furunculosis
4
<1
Herpes Simplex
4
1
Bronchitis
3
2
Sepsis
3
2
Urinary Tract Infection
3
3
Abscess, Skin
2
4
Moniliasis, Oral
2
<1
Mycotic Infection, Skin
<1
3
Osteomyelitis
1
0
The drug relatedness of the adverse events listed below cannot be excluded. The following adverse events occurred in 3% to 10% of Nipent-treated patients in the initial phase of the SWOG study:
Body as a Whole—Chest Pain, Death, Face Edema, Peripheral Edema
Cardiovascular System—Hemorrhage, Hypotension
Digestive System—Dental Abnormalities, Dyspepsia, Flatulence, Gingivitis
Hemic and Lymphatic System—Agranulocytosis
Laboratory Deviations—Elevated Creatinine
Musculoskeletal System—Arthralgia
Nervous System—Confusion, Dizziness, Insomnia, Paresthesia, Somnolence
Psychobiologic Function—Anxiety, Depression, Nervousness
Respiratory System—Asthma
Skin & Appendages—Skin Dry, Urticaria
The remaining adverse events which occurred in less than 3% of Nipent-treated patients during the initial phase of the SWOG study:
Body as a Whole—Flu-like Symptoms, Hangover Effect, Neoplasm
Cardiovascular System—Angina Pectoris, Arrhythmia, A-V Block, Bradycardia, Extrasystoles Ventricular, Heart Arrest, Heart Failure, Hypertension, Pericardial Effusion, Phlebitis, Pulmonary Embolus, Sinus Arrest, Tachycardia, Thrombophlebitis Deep, Vasculitis
Digestive System—Constipation, Dysphagia, Glossitis, Ileus
Hemic and Lymphatic System—Acute Leukemia, Anemia-Hemolytic, Aplastic Anemia
Laboratory Deviations—Hypercalcemia, Hyponatremia
Musculoskeletal System—Arthritis, Gout
Nervous System—Amnesia, Ataxia, Convulsions, Dreaming Abnormal, Dysarthria, Encephalitis, Hyperkinesia, Meningism, Neuralgia, Neuritis, Neuropathy, Paralysis, Syncope, Twitching, Vertigo
Psychobiologic Function—Decrease/Loss Libido, Emotional Lability, Hallucination, Hostility, Neurosis, Thinking Abnormal
Respiratory System—Bronchospasm, Larynx Edema
Skin and Appendages—Acne, Alopecia, Eczema, Petechial Rash, Photosensitivity Reaction
Special Senses—Amblyopia, Deafness, Earache, Eyes Dry, Labyrinthitis, Lacrimation Disorder, Nonreactive Eye, Photophobia, Retinopathy, Tinnitus, Unusual Taste, Vision Abnormal, Watery Eyes
Urogenital System—Amenorrhea, Breast Lump, Impotence, Kidney Function Abnormal, Nephropathy, Renal Failure, R